Lamotrigine Er Tablet, Film Coated, Extended Release
NDC Package 72189-560-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Lamotrigine Er tablets is a medication used to prevent or control seizures (epilepsy). This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Direct_rx, this product is identified by NDC 72189-560 and is authorized under FDA application ANDA213949.

Identification & Billing

NDC Package Code
72189-560-30
Package Description
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
72189-560
11-Digit Billing Format
72189056030
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 900156 - lamoTRIgine 200 MG 24HR Extended Release Oral Tablet
  • RxCUI: 900156 - 24 HR lamotrigine 200 MG Extended Release Oral Tablet
  • RxCUI: 900156 - lamotrigine 200 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Lamotrigine Er
Non-Proprietary Name
Lamotrigine Er
Substance Name
Lamotrigine
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LAMOTRIGINE 200 mg/1
Pharmacologic Class
Usage Information
This product is used to prevent or control seizures (epilepsy). This drug is not approved for use in children younger than 2 years due to an increased risk of side effects (such as infections).

Regulatory & Marketing

Labeler Name
Direct_rx
Product Type
Human Prescription Drug
FDA Application #
ANDA213949
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-19-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72189-560-30 identifies a specific commercial package of 30 tablet, film coated, extended release in 1 bottle of Lamotrigine Er, a human prescription drug labeled by Direct_rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet, film coated, extended release is formulated for oral use and contains lamotrigine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Direct_rx on June 19, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to prevent or control seizures (epilepsy). This drug is not approved for use in children younger than 2 years due to an increased risk of side effects (such as infections).

How is this Direct_rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189056030. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
72189-560-30
11-Digit CMS (5-4-2)
72189-0560-30

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.